NCT06248242

Brief Summary

In this study, a multicenter, randomized, controlled, prospective cohort study was conducted to observe the effect of Edaravone Dexborneol on the incidence and outcome of bleeding transformation after thrombolysis in acute ischemic stroke. To explore the methods to reduce the dilemma of bleeding transformation after thrombolysis, and to dynamically detect the changes of the main links causing bleeding transformation such as blood-brain barrier damage, local immune response activation and so on. To explore the mechanism of Edaravone Dexborneol in reducing bleeding transformation. It is proved that Edaravone Dexborneol combined with thrombolytic therapy can reduce the risk of bleeding and transformation after thrombolysis and improve the safety of thrombolysis. Secondly, it can improve the early recanalization rate of ischemic stroke patients after thrombolytic therapy, and effectively protect the integrity of the blood-brain barrier.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 8, 2024

Status Verified

December 1, 2023

Enrollment Period

3.1 years

First QC Date

January 17, 2024

Last Update Submit

January 30, 2024

Conditions

Acute Ischemic Stroke

Keywords

Edaravone dexborneolrecombinant tissue-type plasminogen activatorAcute cerebral infarction

Outcome Measures

Primary Outcomes (1)

  • Comparison of neurological function between the two groups

    The NIHSS score will be evaluated in both groups on the first day of admission, and at 12 days and 3 months of follow-up. The higher the score, the more serious the neurological function defect, and the less effective the treatment.

    baseline, day 12 and month 3

Study Arms (2)

The control group

NO INTERVENTION

The control group received basic treatment following intravenous drip of rt-PA (specification: 50 mg), including statins and drugs that improve circulation.

The edaravone dexborneol group

EXPERIMENTAL

The edaravone dexborneol group received an injection of concentrated edaravone dexborneol solution (specifications: edaravone, 10 mg and dexborneol, 2.5 mg in a 5 mL solution) and 0.9% sodium chloride injection \[(100 mL), intravenous infusion twice per day, completed within 30 minutes\]. The time between the two doses was no less than 6 hours, and each cycle lasted 12 days.

Drug: Edaravone dexborneol

Interventions

Edaravone dexborneolDRUG

edaravone 10 mg and dexborneol 2.5 mg twice daily

The edaravone dexborneol group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients met the diagnostic criteria of the Chinese acute ischemic stroke diagnosis and treatment guidelines.
  • Patients developed clinical symptoms for the first time, with an onset time of less than 4.5 hours.
  • Patients with the National Institutes of Health Stroke Scale (NIHSS) neurological deficit score was ≥4.
  • The study was approved by the hospital's theoretical committee and the patients provided consent.

You may not qualify if:

  • Patients were allergic to the drugs used in this study.
  • Patients with a history of intracranial hemorrhage or subarachnoid hemorrhage, a recent history of head trauma, myocardial infarction, hemorrhage, and major surgical surgery
  • Patients with cerebral hemorrhage and large-area imaging cerebral infarction characteristics
  • Patients with severe infection, immune system and blood system diseases
  • Patients with severe injury to other important organs
  • Patients with severe coma or mental disorders
  • Patients undergoing surgical treatment within 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Guojun Tan, Dr

    The Second Hospital of Hebei Medical University

    STUDY CHAIR

Central Study Contacts

Guojun Tan, Dr

CONTACT

15803210587tandyshine@163.com

Boxu Xie

CONTACT

15383935253xiebx1999@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 8, 2024

Study Start

June 1, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 8, 2024

Record last verified: 2023-12

Locations

CN(1)